DEVICE: Navarre Opti-Drain (00801741037108)
Device Identifier (DI) Information
Navarre Opti-Drain
NOD8PT
In Commercial Distribution
NOD8PT
Bard Access Systems, Inc.
NOD8PT
In Commercial Distribution
NOD8PT
Bard Access Systems, Inc.
Navarre Opti-Drain Multi-Use Drainage Catheter, Pigtail, 8 Fr x 30 cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
11305 | Closed-wound drain, non-bioabsorbable |
A tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GBX | CATHETER, IRRIGATION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 30 Centimeter |
Catheter Gauge: 8 French |
Device Record Status
3ef553a2-0cc3-4ba7-b45f-0011b1e88dac
October 25, 2022
1
October 17, 2022
October 25, 2022
1
October 17, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10801741037105 | 5 | 00801741037108 | In Commercial Distribution | CA |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)545-0890
medical.services@BD.com
medical.services@BD.com